Table 5.
Factors significantly associated with adverse events classified according to (a) severity and (b) occurrence as reported in the literature following the first and second dose of vaccine
| (a) | I dose | II dose | ||||
|---|---|---|---|---|---|---|
| Yes N (%) |
No N (%) |
p-value | Yes N (%) |
No N (%) |
p-value | |
| Mild events | ||||||
| Sex | ||||||
| Female | 179 (85.6) | 30 (14.4) | 0.005* | 175 (83.7) | 34 (16.3) | 0.044* |
| Male | 96 (73.3) | 35 (26.7) | 98 (74.8) | 33 (25.2) | ||
| Reference age class | ||||||
| ≤ 55 years | 193 (86.5) | 30 (13.5) | < 0.001* | 193 (86.5) | 30 (13.5) | < 0.001* |
| > 55 years | 82 (70.1) | 35 (29.9) | 80 (68.4) | 37 (31.6) | ||
| Median age | ||||||
| ≤ 49 years | 150 (87.7) | 21 (12.3) | 0.001* | 146 (85.4) | 25 (14.6) | 0.018* |
| > 49 years | 125 (74.0) | 44 (26.0) | 127 (75.1) | 42 (24.9) | ||
| History of SARS-CoV-2 infection | ||||||
| Yes | 18 (100) | 0 (0) | 0.030§ | 16 (88.9) | 2 (11.1) | 0.543§ |
| No | 257 (79.8) | 65 (20.2) | 257 (79.8) | 65 (20.2) | ||
| Vaccinations in the past 6 months | ||||||
| Yes | 67 (75.3) | 22 (24.7) | 0.118* | 65 (73.0) | 24 (21.0) | 0.045* |
| No | 208 (82.9) | 43 (17.1) | 208 (82.9) | 43 (17.1) | ||
| Moderate events | ||||||
| Sex | ||||||
| Female | 30 (14.3) | 179 (85.7) | 0.061* | 97 (46.4) | 112 (53.6) | < 0.001* |
| Male | 10 (7.6) | 121 (92.4) | 29 (22.1) | 102 (77.9) | ||
| History of SARS-CoV-2 infection | ||||||
| Yes | 9 (50.0) | 9 (50.0) | < 0.001§ | 10 (55.6) | 8 (44.4) | 0.095* |
| No | 31 (9.6) | 291 (90.4) | 116 (36.0) | 206 (64.0) | ||
| Vaccinations in the past 6 months | ||||||
| Yes | 8 (9.0) | 81 (91.0) | 0.344* | 25 (28.1) | 64 (71.9) | 0.041* |
| No | 32 (12.7) | 219 (87.3) | 101 (40.2) | 150 (59.8) | ||
| Severe events | ||||||
| Sex | ||||||
| Female | 12 (5.7) | 197 (94.3) | 0.020* | 15 (7.1) | 194 (92.8) | 0.007* |
| Male | 1 (0.8) | 130 (99.2) | 1 (0.8) | 130 (99.2) | ||
| (b) | I dose | II dose | ||||
|---|---|---|---|---|---|---|
| Yes N (%) |
No N (%) |
p-value | Yes N (%) |
No N (%) |
p-value | |
| Very common events | ||||||
| Sex | ||||||
| Female | 181 (86.6) | 28 (13.4) | 0.004* | 176 (84.2) | 33 (15.8) | 0.033* |
| Male | 97 (74.0) | 34 (26.0) | 98 (74.8) | 33 (25.2) | ||
| Age | ||||||
| ≤ 49 years | 152 (88.9) | 19 (11.1) | 0.001* | 145 (84.8) | 26 (15.2) | 0.049* |
| > 49 years | 126 (74.6) | 43 (25.4) | 129 (76.3) | 40 (23.7) | ||
| Age | ||||||
| ≤ 55 years | 195 (87.4) | 28 (12.6) | < 0.001* | 192 (86.1) | 31 (13.9) | < 0.001* |
| > 55 years | 83 (70.9) | 34 (29.1) | 82 (70.1) | 35 (29.9) | ||
| Vaccinations in the past 6 months | ||||||
| Yes | 68 (76.4) | 21 (23.6) | 0.127* | 65 (73.0) | 24 (27.0) | 0.036* |
| No | 210 (83.7) | 41 (16.3) | 209 (83.3) | 42 (16.7) | ||
| Common events | ||||||
| Sex | ||||||
| Female | 35 (16.7) | 174 (83.3) | 0.004* | 59 (28.2) | 150 (71.8) | 0.001* |
| Male | 8 (6.1) | 123 (93.9) | 16 (12.2) | 115 (87.8) | ||
| Professional activity | ||||||
| HCWs | 36 (13.7) | 227 (86.3) | 0.286* | 65 (24.7) | 67 (75.3) | 0.029* |
| Non-HCWs | 7 (9.1) | 70 (90.9) | 10 (13.0) | 198 (87.0) | ||
| History of SARS-CoV-2 infection | ||||||
| Yes | 8 (44.5) | 10 (55.5) | 0.001§ | 4 (28.6) | 14 (71.4) | > 0.999§ |
| No | 35 (10.9) | 287 (89.1) | 71 (22.0) | 251 (77.8) | ||
| Any COVID-19 symptoms | ||||||
| Yes | 8 (53.4) | 7 (46.6) | < 0.001§ | 4 (26.7) | 11 (73.3) | 0.750§ |
| No | 35 (10.8) | 290 (89.2) | 71 (21.8) | 254 (78.2) | ||
| Uncommon events | ||||||
| Sex | ||||||
| Female | 8 (3.8) | 201 (96.2) | 0.025§ | 6 (2.9) | 203 (97.1) | 0.716§ |
| Male | 0 (0) | 131 (100) | 2 (1.5) | 129 (98.5) | ||
| History of SARS-CoV-2 infection | ||||||
| Yes | 4 (22.2) | 14 (77.8) | < 0.001§ | 0 (0) | 18 (100) | > 0.999§ |
| No | 4 (1.2) | 318 (98.8) | 8 (2.5) | 314 (97.5) | ||
| Any COVID-19 symptoms | ||||||
| Yes | 4 (26.7) | 11 (73.3) | < 0.001§ | 0 (0) | 15 (100) | > 0.999§ |
| No | 4 (1.2) | 321 (98.8) | 8 (2.4) | 317 (97.6) | ||
*Chi-square test; §Fisher’s Exact test; significant results (p < 0.05) are indicated in bold